Toripalimab With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Last updated: February 8, 2022
Sponsor: Sichuan Cancer Hospital and Research Institute
Overall Status: Active - Not Recruiting

Phase

2

Condition

Esophageal Cancer

Squamous Cell Carcinoma

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT04177797
SCCH-TS2001
  • Ages 18-75
  • All Genders

Study Summary

This is a single-institution, single arm trial of Toripalimab with neoadjuvant carboplatin and paclitaxel for locally advanced esophageal squamous cell carcinoma (ESCC).The primary study hypothesis is that the patients who received Toripalimab combined with carboplatin and paclitaxel will increase complete pathologic response rate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Histologically confirmed ESCC;
  • 2.Clinical stage T1-2N2-3M0 or T3N1-3M0 or T4N0-3M0(AJCC 8 TNM classification);
  • 3.Have a performance status of 0 or 1 on the ECOG Performance Scale;
  • 4.The important organs functions meet the following requirements:the absoluteneutrophil count(ANC) ≥1.5×109/L; the platelet count ≥100×109/L; hemoglobin ≥90g/L;bilirubin is less than or equal to 1.5 times ULN, ALT and AST less than or equal 2.5times UILN; creatinine clearance rate(CCr) ≥50mL/min; the thyroid function is normal;
  • 5.Expected survival time is greater than or equal to 3 months;
  • 6.Female subjects of childbearing potential should have a negative urine or serumpregnancy within 72 hours prior to receiving the first dose of study medication. Ifthe urine test is positive or cannot be confirmed as negative, a serum pregnancy testwill be required;
  • 7.Female subjects of childbearing potential must be willing to use an adequate methodof contraception - Contraception, for the course of the study through 90 days afterthe last dose of study medication;
  • 8.Be willing and able to provide written informed consent/assent for the trial.

Exclusion

Exclusion Criteria:

  • 1.Has any active autoimmune disease or a history of autoimmune disease;
  • 2.The patient is receiving systemic steroid therapy or any other form ofimmunosuppressive therapy;
  • 3.The patient had active infection, fever of unknown cause ≥38.5℃ within 7 days beforethe medication, or white blood cell count at baseline >15×109/L;
  • 4.The patient had previously received other anti-pd-1 antibody therapy or otherimmunotherapy targeting pd-1 / pd-L1,or received chemoradiotherapy;
  • 5.Have a history of mental illness or psychiatric substance abuse;
  • 6.Patients who had participated in clinical trials of other drugs within 4 weeks;
  • 7.Patients with a serious risk to treating patients' safety or a concomitant diseasethat affects the completion of the study according to the researchers judgment;
  • 8.Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
  • 9.Other patients whom the medical practitioner considers inappropriate for inclusion.

Study Design

Total Participants: 20
Study Start date:
March 20, 2020
Estimated Completion Date:
December 31, 2023

Study Description

Enrolled patinets will receive two cycles of Toripalimab(240 mg administered as an intravenous infusion over 30 minutes per 3 weeks), paclitaxel(135 mg/m2) and carboplatin(AUC 5) administered as an intravenous infusion per 3 weeks. Giving the drugs on the first day of each cycle.

Connect with a study center

  • Sichuan Cancer Hospital and Research Institute

    Chengdu, Sichuan 610041
    China

    Site Not Available

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